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RISK ASSESSMENTREFERENCE OUTLINE
Environmental Monitoring Risk Assessment (EMRA)
Risk-based EM program design template. Identifies critical sampling locations, justifies frequencies, and documents alert/action level rationale per USP <1116>.
REGULATIONS MAPPED
USP <1116>EU GMP Annex 1 (2022)ISO 14644-2
DOCUMENT TYPE
Risk AssessmentLAST UPDATED
September 2024PURPOSE
A risk-based environmental monitoring program design that justifies sampling locations, frequencies, and alert/action levels using documented rationale rather than historical habit.
What's Inside
✓Cleanroom classification and zone mapping
✓Risk-ranking of candidate sampling locations
✓Frequency justification matrix
✓Alert/action level derivation
✓Excursion-response linkage
How to Use It
1Map all classified areas and their process risk
2Score each candidate location by proximity to product and personnel exposure
3Set frequencies proportionate to risk
4Derive alert/action levels from qualification data and USP <1116>
5Connect the program to your trending and excursion SOPs
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose, Scope, and References
2Cleanroom Classification and Zone Map
3Risk-Ranking Methodology for Sampling Locations
4Viable and Non-Viable Location Schedule
5Frequency Justification Matrix
6Alert and Action Level Derivation
7Excursion Investigation Linkage
8Program Review and Re-assessment Triggers
REGULATORY CONTEXT
USP <1116> and EU GMP Annex 1 (2022) expect a scientifically justified EM program. This template documents that justification for inspection.